FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094147803
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901071
Catalog number
408875
Device description
590 VAG SPEC X SMALL
Published
2017-12-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIBSpeculum, vaginal, nonmetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIBSpeculum, Vaginal, NonmetalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094102123PackageGS11Not in Commercial Distribution
00732094147797PackageGS124Not in Commercial Distribution
00732094147803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094102123007320941021237320941021230732094102123
00732094147797007320941477977320941477970732094147797
00732094147803007320941478037320941478030732094147803

GMDN Terms#

Term, Definition table
TermDefinition
Artificial airway stylet, single-useA long stiffening wire/rod designed for insertion within the lumen of an artificial airway tube (e.g., endotracheal tube, bronchial tube) to stiffen and/or maintain the shape of the tube to facilitate introduction (intubation). It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834gdsn_support@MyHillRom.onmicrosoft.com

Regulatory Flags#

DUNS number
198227881
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094084610Welch Allyn, Inc.901092DS45-112016-09-17
00732094089479Welch Allyn, Inc.901081117202016-09-17
00817655023106Welch Allyn, Inc.9011454197342019-10-23
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094319903Welch Allyn, Inc.9010114198322023-09-26
00732094326079Welch Allyn, Inc.9010069293-024-512023-08-25
00732094247138Welch Allyn, Inc.90103139500-TE2019-08-28
00732094247145Welch Allyn, Inc.90103139500-NP-TE2019-08-28
00732094272338Welch Allyn, Inc.90115211094-001-502020-03-24
00732094258905Welch Allyn, Inc.90113411012-014-502020-03-20
00732094307351Welch Allyn, Inc.9011454197512019-10-23
00732094307368Welch Allyn, Inc.9011454133792019-10-23
00732094307375Welch Allyn, Inc.9011454197332019-10-23
00732094258998Welch Allyn, Inc.901011036840-0052019-09-26
00732094272673Welch Allyn, Inc.901011036840-0062019-09-26
00817655020679Welch Allyn, Inc.90113411012-016-502019-09-26
00817655020686Welch Allyn, Inc.90113411012-016-512019-09-26
00732094296341Welch Allyn, Inc.90101211093-003-502019-06-11
00732094223910Welch Allyn, Inc.9011084112152023-08-24

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Primary DI, Brand, Company table
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10860008900309ClearSpecClearspec LLCHIB2025-10-29
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10860008900323ClearSpecClearspec LLCHIB2025-10-29